Influence of Vaginal Lactoferrin on Amniotic Fluid Cytokines to Avoid Pregnancy Complications

• Sponsor: Università degli Studi di Ferrara (Other)
• Overall Status: Completed
• CT.gov ID: NCT02843984
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 3
• Duration (Months): 12
• Patients Per Site Per Month: 5

Study Details

Study Description

Brief Summary

Objective: To evaluate the influence of vaginal Lactoferrin administration on amniotic fluid concentration of 47 cytokines, chemokines and growth factors.

Condition or Disease	Intervention/Treatment	Phase
Pregnancy	Drug: Lactoferrin	N/A

Detailed Description

60 women undergoing genetic amniocentesis will be enrolled at the Obstetric Unit, University of Ferrara. The selected patients will be randomly assigned to receive 300 mg of vaginal Lactoferrin to obtain 3 groups: A, 20 untreated patients; B and C (20 patients each one) respectively treated 4 and 12 h before amniocentesis. Cytokines, chemokines and growth factors concentrations will be quantified by a magnetic bead Luminex multiplex immunoassays panel technology.

Amniotic fluid samples will be obtained by transabdominal amniocentesis and the sample not required for clinical purposes will be centrifuged to remove particulate material and the supernatants will be aliquoted and stored at -80°C until assay.

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Study Start Date: Mar 1, 2011
• Actual Primary Completion Date: Mar 1, 2012
• Actual Study Completion Date: Mar 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: A - untreated The patients will be not treated with vaginal lactoferrin
Active Comparator: B - 4 hrs treatment The patients will be administered with a single dose of 300 mg vaginal lactoferrin 4 hours prior to mid-trimester genetic amniocentesis.	Drug: Lactoferrin
Active Comparator: C - 12 hrs treatment The patients will be administered with a single dose of 300 mg vaginal lactoferrin 12 hours prior to mid-trimester genetic amniocentesis.	Drug: Lactoferrin

Outcome Measures

Primary Outcome Measures

1. Amniotic fluid concentration of mediators involved in inflammation [1 month after the enrollment of patients will be concluded.]

   The investigator will measure the amniotic fluid concentration of 47 mediators (cytokines, chemokines and growth factors) involved in the inflammatory process by Luminex multiplex immunoassays. Controls and Lactoferrin-treated patients will be compared by parametric or non-parametric statistical tests.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• singleton physiological pregnancy;

• maternal age as the only indication to foetal karyotyping

Exclusion Criteria:

• assumption of drugs interfering with the immune system;

• previous miscarriages;

• pregnancy at risk for maternal or foetal disease;

• lactose intolerance.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Obstetric Unit, University of Ferrara	Cona	Ferrara	Italy	44124

Sponsors and Collaborators

• Università degli Studi di Ferrara

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alessandro Trentini, PhD, Università degli Studi di Ferrara
• ClinicalTrials.gov Identifier: NCT02843984
• Other Study ID Numbers: PRUa1GR-2013-00000220-B
• First Posted: Jul 26, 2016
• Last Update Posted: Jul 26, 2016
• Last Verified: Jul 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Alessandro Trentini, PhD, Università degli Studi di Ferrara: Amniocentesis
• Additional relevant MeSH terms: Lactoferrin

Study Results

No Results Posted as of Jul 26, 2016